Methotrexate in combination with other DMARDs is not superior to methotrexate alone for remission induction with moderate-to-high-dose glucocorticoid bridging in early rheumatoid arthritis after 16 weeks of treatment: the CareRA trial. Issue 1 (30th October 2014)

• Record Type: Journal Article
• Authors: Verschueren, P; De Cock, D; Corluy, L; Joos, R; Langenaken, C; Taelman, V; Raeman, F; Ravelingien, I; Vandevyvere, K; Lenaerts, J; Geens, E; Geusens, P; Vanhoof, J; Durnez, A; Remans, J; Vander Cruyssen, B; Van Essche, E; Sileghem, A; De Brabanter, G; Joly, J; Meyfroidt, S; Van der Elst, K; Westhovens, R
• Other Names: Maeyaert B author non-byline.; De Brabanter G author non-byline.; Devinck M author non-byline.; Langenaken C author non-byline.; Lenaerts J author non-byline.; Corluy L author non-byline.; Remans J author non-byline.; Vander Cruyssen B author non-byline.; Ravelingien I author non-byline.; Van Essche E author non-byline.; Vandevyvere K author non-byline.; Durnez A author non-byline.; Verbruggen A author non-byline.; Geens E author non-byline.; Raeman F author non-byline.; Joos R author non-byline.; de Vlam K author non-byline.; Taelman V author non-byline.; Vanhoof J author non-byline.; Coppens M author non-byline.; Geusens P author non-byline.; Sileghem A author non-byline.; Volders P author non-byline.; Van Den Bosch F author non-byline.; Verschueren P author non-byline.; Westhovens R author non-byline.
• Is Part Of: Annals of the rheumatic diseases. Volume 74:Issue 1(2015)
• Page Start: 27
• Page End: 34
• Publication Date: 2014-10-30
• Subjects: Early Rheumatoid Arthritis -- DMARDs (synthetic) -- Corticosteroids -- Methotrexate -- Outcomes research; Rheumatism -- Periodicals; 616.723005
• DOI: 10.1136/annrheumdis-2014-205489
• Languages: English
• ISSNs: 0003-4967

Abstract

Abstract : Objectives: To compare the efficacy and safety of intensive combination strategies with glucocorticoids (GCs) in the first 16 weeks (W) of early rheumatoid arthritis (eRA) treatment, focusing on high-risk patients, in the Care in early RA trial. Methods: 400 disease-modifying antirheumatic drugs (DMARD)-naive patients with eRA were recruited and stratified into high risk or low risk according to classical prognostic markers. High-risk patients (n=290) were randomised to 1/3 treatment strategies: combination therapy for early rheumatoid arthritis (COBRA) Classic (methotrexate (MTX)+ sulfasalazine+60 mg prednisone tapered to 7.5 mg daily from W7), COBRA Slim (MTX+30 mg prednisone tapered to 5 mg from W6) and COBRA Avant-Garde (MTX+leflunomide+30 mg prednisone tapered to 5 mg from W6). Treatment modifications to target low-disease activity were mandatory from W8, if desirable and feasible according to the rheumatologist. The primary outcome was remission (28 joint disease activity score calculated with C-reactive protein <2.6) at W16 (intention-to-treat analysis). Secondary endpoints were good European League Against Rheumatism response, clinically meaningful health assessment questionnaire (HAQ) response and HAQ equal to zero. Adverse events (AEs) were registered. Results: Data from 98 Classic, 98 Slim and 94 Avant-Garde patients were analysed. At W16, remission was reached in 70.4% Classic, 73.6% Slim and 68.1% Avant-Garde patients (p=0.713). Likewise, no significant differences were shown in other secondary endpoints. However, therapy-related AEs were reported in 61.2% of Classic, in 46.9% of Slim and in 69.1% of Avant-Garde patients (p=0.006). Conclusions: For high-risk eRA, MTX associated with a moderate step-down dose of GCs was as effective in inducing remission at W16 as DMARD combination therapies with moderate or high step-down GC doses and it showed a more favourable short-term safety profile. EudraCT number: 2008-007225-39.